Lifeboat Foundation

Tell the FDA to identify and punish organisations who have broken US law by not reporting clinical trial results.

The US’s Food and Drug Administration has at last published its plan to identify and punish the organisations and people who have broken the law by not reporting clinical trial results. The FDA now wants to hear what we think about the plan.

The FDA Amendment Act 2007 says that lots of clinical trials in the US should be registered on ClinicalTrials.gov and report results information there within 12 months of the end of the trial. AllTrials’s FDAAA TrialsTracker shows that 628 clinical trials have broken this law since the first trials became due in January this year. We have written to the FDA every week to update them on the trials that have breached the law and shared with them a rolling estimation of the amount in fines the Agency could levy on the law breakers. The FDA has the power to fine people up to $10,000 a day and we have assessed that they could have raised $904,499,127 – nearly a billion dollars – but no one has ever been fined. That the FDA is now seriously considering how to start doing this is a long-awaited step forward.

Continue reading “Tell the FDA to identify and punish law breakers” »

Motivational speaker Emile Ratelband compares bid to alter age to gender change.

Should there be any ethical or legal boundaries to technologies that enhance humans? I pondered this last week as I read an online article about the recent trials of upper-body “exoskeletons” by production line staff at Volkswagen and at Chrysler-Fiat. These lightweight wearable frames greatly reduce the physical strain of repetitive overhead assembly work, and will be an important industrial enhancement as workforces age.

We tend to think of medical advancement in terms of better cures for diseases and recovery from injury. Enhancement however goes beyond therapy, and extends us in ways that some may argue are unnatural. Some human enhancements are of course also pre-emptive therapeutic interventions. Vaccination is both an enhancement of our immune system, and a therapeutic intervention. However, in cases where there is little preventative justification, what degree of enhancement is acceptable?

We drink coffee expecting our work performance to improve. We accept non-elective operations, breast implants, orthodontic improvements and other interventions which improve our perception of ourselves. We generally accept such enhancements with little question. However devices and drugs that improve athletic performance can lead us to question their legitimacy.

Continue reading “To be – or not to be – an enhanced human” »

Authorities in China’s far-western Xinjiang region appear to have officially legalized so-called re-education camps for people accused of religious extremism, a little more than a month after denying such centers exist.

The Xinjiang government on Tuesday revised a local law to encourage “vocational skill education training centers” to “carry out anti-extremist ideological education.”

Human rights organizations have long alleged the Chinese government has been detaining hundreds of thousands of Uyghurs — a Turkic-speaking, largely Muslim minority native to Xinjiang — in such centers as part of an effort to enforce patriotism and loyalty to Beijing in the region.

Continue reading “China legalizes Xinjiang ‘re-education camps’ after denying they exist” »

The 2018 FAA Reauthorization Act maintains a distinction between recreational and commercial activities, but the FAA is no longer constrained by law not to impose rules on the former: Section 336, which had previously carved out an exception for model aircraft, has been entirely repealed. In its place is a new Section 349, which covers what the FAA expects of recreational flyers.

The title of Section 349 betrays a very different attitude compared with the earlier Section 336. It reads: “Exception for Limited Recreational Operations of Unmanned Aircraft.” No more calling them model aircraft: Small models—including things sold as toys, even paper airplanes—are referred to as “Unmanned Aircraft.”

That seems a little ridiculous to me. In my view, the FAA is committing what philosophers sometimes call the fallacy of the beard: A paper airplane is clearly not something the FAA should worry about, whereas a large octocopter with whirring blades carrying a heavy camera is. But where do you draw the line? The FAA refuses to set a threshold under which it bows out, insisting that everything not carrying people and capable of flight is an “unmanned aircraft” requiring the agency’s oversight and regulation.

Continue reading “New FAA Rules for Drones Go Into Effect” »

Today, we have a talk by Dr. Alvaro Macieira-Coelho, who discusses how aging is a consequence of thermodynamics and entropy. Quite simply, aging is the default for most species.

Earlier this year, we hosted the Ending Age-Related Diseases 2018 conference at the Cooper Union, New York City. The event was focused on bringing the worlds of research and investment in the rejuvenation biotechnology field together and saw a number of talks and panels focused on research and investment.

Continue reading “Aging Happens” »

A comparison of surveys taken of the sky years apart has revealed an empty space where a star 280 million light years away once sat.

Coded FIRST J1419+3940, records of the object hint at what would have been a violent death. Curiously, no trace of its final explosive moments can be found – but this ghostly silence has only made astronomers all the more excited.

“We compared images from old maps of the sky and found one radio source that was no longer visible today in the Very Large Array Sky Survey (VLASS),” says astronomer Casey Law from the University of California, Berkeley.

Continue reading “Astronomers Are Getting Excited Over Ghostly Traces of a Massive Cosmic Explosion” »

(CNN) — Scientists believe a fossil found at a landfill in California belongs to an extinct species of whale that lived between 4 and 7 million years ago.

The seven-ton fossil was unearthed in June during a construction excavation at the Prima Deshecha landfill in San Juan Capistrano, Orange County Waste & Recycling announced in a statement.

Continue reading “Scientists may have uncovered an entire new whale species” »

California Governor Jerry Brown has signed a cybersecurity law covering “smart” devices, making California the first state with such a law. The bill, SB-327, was introduced last year and passed the state senate in late August.

Starting on January 1st, 2020, any manufacturer of a device that connects “directly or indirectly” to the internet must equip it with “reasonable” security features, designed to prevent unauthorized access, modification, or information disclosure. If it can be accessed outside a local area network with a password, it needs to either come with a unique password for each device, or force users to set their own password the first time they connect. That means no more generic default credentials for a hacker to guess.

The bill has been praised as a good first step by some and criticized by others for its vagueness. Cybersecurity expert Robert Graham has been one of its harshest critics. He’s argued that it gets security issues backwards by focusing on adding “good” features instead of removing bad ones that open devices up to attacks. He praised the password requirement, but said it doesn’t cover the whole range of authentication systems that “may or may not be called passwords,” which could still let manufacturers leave the kind of security holes that allowed the devastating Mirai botnet to spread in 2016.

Continue reading “California just became the first state with an Internet of Things cybersecurity law” »